Research Study of a Levonorgestrel 52 MG IUD for the treatment of heavy menstrual bleeding

  • STATUS
    Recruiting
  • participants needed
    15
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Updated on 19 February 2024

Summary

Healthy women 18 to 50 years of age who are seeking treatment for heavy menstrual bleeding and do not wish to become pregnant during the next ten months are invited to participate.

Description

This study is being conducted at The University of Pennsylvania and will use a hormonal intrauterine device (IUD) that is already on the market in the United States.  The IUD is called Liletta®. Liletta was first approved by the Food and Drug Administration (FDA) for contraception (birth control) in 2015.  It is currently approved for women to use for contraception for up to 5 years.  This IUD is a small device with a hormone in it that is placed into your uterus by a study doctor.  The IUD releases a small amount of the hormone into the uterus every day for several years. This investigational drug study is being done to evaluate if this IUD is safe and effective treatment for women with heavy menstrual bleeding. 

If you agree to participate, you will be one of about 100 women involved in this study in the United States. You will be one of up to 15 women invited to take part in this study at this study site. Your total participation in the study may last up to approximately 10 months (3 to 4 months screening and 6 months of study treatment). You will need to come to the clinic for up to 8 scheduled visits, and may have 1 contact by telephone or e-mail for follow-up to check on your progress after the end of the treatment. Additional contacts may be made to schedule or confirm your study visits.

FAQ

To see if you are eligible for the study, please complete the prescreener where you will be asked personal health questions. You don't have to answer any question you don't want to answer. Your answers will be recorded but your information will only be used for the purposes of this study. If you have any questions, you can contact someone from the study at 215-712-8125.

Details
Condition menstrual,heavy period,heavy menstrual,women's health
Age 18years - 50years
Clinical Study IdentifierTX6135
Last Modified on19 February 2024

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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